Healthcare Industry News: Xibrom
News Release - November 17, 2010
ISTA Pharmaceuticals Granted Three-Year Market Exclusivity for BROMDAYShips First Orders
IRVINE, Calif., Nov. 17, 2010 -- (Healthcare Sales & Marketing Network) -- ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA ), today announced the U.S. Food and Drug Administration (FDA) has granted the Company three years of marketing exclusivity for BROMDAY™ (bromfenac ophthalmic solution) 0.09%, as provided under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. BROMDAY (formerly referred to as XiDay), the first and only once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction, was approved by the FDA in October of 2010. Under the Hatch-Waxman Act, the FDA may not approve an Abbreviated New Drug Application for a generic version of BROMDAY until October of 2013.
BROMDAY is a once-daily eye drop formulation of a nonsteroidal anti-inflammatory compound for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. BROMDAY is approved for dosing once-daily beginning one day prior to surgery, on the day of surgery and continuing for the first 14 days after surgery. Since 2005, ISTA has marketed Xibrom (bromfenac ophthalmic solution)® 0.09% in the U.S. for twice-daily use for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. ISTA acquired U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. Xibrom is the 2010 dollar market share leader in the $335 million U.S. ophthalmic nonsteroidal anti-inflammatory market. ISTA reported Xibrom net sales of $81.1 million for the year ended December 31, 2009, and net sales of $71 million in the first nine months of 2010, up 29% over the first nine months of 2009.
INDICATIONS AND USAGE
BROMDAY is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
DOSAGE AND ADMINISTRATION
Instill one drop into the affected eye(s) once-daily beginning 1 day prior to surgery, continued on the day of surgery and through the first 14 days post-surgery.
DOSAGE FORMS AND STRENGTHS
Topical ophthalmic solution: bromfenac 0.09%
WARNINGS AND PRECAUTIONS
* Sulfite Allergic Reactions
* Slow or Delayed Healing
* Potential for cross-sensitivity
* Increased bleeding of ocular tissues
* Corneal effects including keratitis
* Contact Lens Wear
The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in the eye, conjunctival hyperemia and eye irritation (including burning/stinging).
Full prescribing information for BROMDAY is available on ISTA Pharmaceuticals' website at www.istavision.com/pdf/BROMDAYPI101008.pdf.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc. is the fourth largest and fastest growing branded prescription eye care business in the United States, with an expanding focus on allergy therapeutics. ISTA currently markets five products, including treatments for ocular inflammation and pain associated with cataract surgery, glaucoma, and ocular itching associated with allergic conjunctivitis. The Company's development pipeline contains additional candidates in various stages of development to treat dry eye, ocular inflammation and pain, and nasal allergies. Headquartered in Irvine, California, the Company generated 2009 revenues of $111 million. For additional information about ISTA Pharmaceuticals, please visit the corporate website at www.istavision.com.
BROMDAY™ (bromfenac ophthalmic solution) 0.09% and Xibrom (bromfenac ophthalmic solution)® 0.09% are trademarks of ISTA Pharmaceuticals, Inc.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to when BROMDAY might be available in pharmacies and ISTA's intention to discontinue marketing and selling Xibrom in 2011 are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency approval or actions and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2009, and its Quarterly Report on Forms 10-Q for the quarters ended March 3, June 30 and September 30, 2010.
Source: ISTA Pharmaceuticals
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